BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROCOL BIOLOGIC VASCULAR GRAFT

    MDR report key: 9047528 · Received September 13, 2019

    Report

    Report Number
    1220948-2019-00129
    Event Type
    Malfunction
    Date Received
    September 13, 2019
    Report Date
    September 13, 2019
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    LXA
    PMA / PMN Number
    P020049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE NOT RECEIVED THE GRAFT FOR EVALUATION. HENCE, WE COULD NOT CONCLUSIVELY DETERMINE THE CAUSE OF THE FAILURE. PROCOL VASCULAR BIOPROSTHESIS IS DERIVED FROM A SINGLE LENGTH OF BOVINE MESENTERIC VEIN THAT IS CHEMICALLY CROSS-LINKED WITH GLUTARALDEHYDE. NATURAL VARIATIONS EVEN IN THE SAME GRAFT IS POSSIBLE. COLLATERAL BRANCHES ARE LIGATED WITH SURGICAL SUTURE AND THE GRAFT IS INSPECTED UNDER PULSATILE FLOW CONDITIONS AT SIMULATED PHYSIOLOGICAL INTERNAL GRAFT PRESSURE. EACH GRAFT IS PRESSURIZED BETWEEN 2.7-4.0 PSI ( 139 - 206 MMHG) DURING INSPECTION PROCESS. IF PRESSURE EXCEEDS 4 PSI, THE VESSEL IS REJECTED FOR 'OVERPRESSURIZED' AND DISCARDED. UNDER PRESSURIZED CONDITION, EACH GRAFT IS INSPECTED BY THE MANUFACTURING OPERATORS FOR ANY PRESENCE OF HOLE, TEAR OR SWELLING. AN OD GAGE IS PASSED OVER THE ENTIRE LENGTH OF THE VESSEL. IF ANY SECTION OF THE GRAFT APPEARED TO BE SWOLLEN OR DID NOT PASS THROUGH THE GAGE SMOOTHLY, THEN THAT SECTION OF THE GRAFT IS REJECTED BY THE TECHNICIAN. EACH GRAFT IS AGAIN INSPECTED BY THE QC TECHNICIAN FOR THESE ATTRIBUTES. BASED ON OUR INVESTIGATION AND OUR SALES REP'S OBSERVATION, THE GRAFT WAS LIKELY DAMAGED DUE TO OVER-PRESSURIZATION WHEN IRRIGATING THE LUMEN OF THE GRAFT PRIOR TO THE PROCEDURE AT THE HOSPITAL. HE OBSERVED THE PREP NURSE TO BE PRESSURIZING THE GRAFT WITH A 20CC SYRINGE PRIOR TO HAND OFF. WITH THIS INFORMATION, WE WERE ABLE TO RECREATE A SIMILAR MALFUNCTION WITH A NEW GRAFT USING A PRESSURE GAUGE. WE OBSERVED PRESSURE AS HIGH AS 15 PSI WHICH IS 5 TIMES HIGHER THAN NORMAL HUMAN BLOOD PRESSURE. OUR SALES REP. IS SCHEDULED TO RETRAIN THE SURGICAL TEAM ON PROPER IRRIGATION PROCEDURE. OUR IFU PROPERLY INSTRUCTS USERS TO USE LIGHT PRESSURE WHEN IRRIGATING THE GRAFT AND NOT TO FLUSH THE GRAFT OPPOSITE THE DIRECTION OF FLOW AS COMPETENT VALVES MAY CAUSE EXCESSIVE PRESSURE AND MAY COMPROMISE THE INTEGRITY OF THE VESSEL. THE IFU ALSO INFORMS USERS NOT TO USE FORCEPS TO GRIP THE GRAFT AS IT MAY DAMAGE THE GRAFT.

    Description of Event or Problem · 1

    DURING A CONVERSATION, SURGEON TOLD SALES REP THAT OVER THE COURSE OF LAST 2-3 WEEK, HE OBSERVED AN ANEURYSM WITH A PROCOL GRAFT. AFTER HE COMPLETED THE ARTERIAL ANASTOMOSIS, UPON PRESSURIZING THE GRAFT, HE OBSERVED AN ANEURYSMAL SPOT ON THE GRAFT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826774 PROCOL BIOLOGIC VASCULAR GRAFT VASCULAR GRAFT LXA LEMAITRE VASCULAR, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1